- Previously enrolled in any of the studies included on the list of approved studies for enrollment into SMARTT or another study with SMARTT Protocol Chair approval if the study has data on ART exposure by pregnancy trimester, ART exposure during the first 2 months of life, and pregnancy complication data or availability of ART exposure by pregnancy trimester (including start and stop dates), ART exposure during the first 2 months of life, and pregnancy complication data in the mother and/or child's medical record.